510(k) K790949
K790949 is an FDA 510(k) premarket notification submitted by Rami International Corp. for the device "GALVANIC UNIT". The FDA issued a decision of Substantially Equivalent on August 16, 1979. The device falls under product code ISB (Stimulator, Muscle, Diagnostic), a Class II device regulated under 21 CFR 890.1850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 1979
- Date Received
- May 21, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Muscle, Diagnostic
- Device Class
- Class II
- Regulation Number
- 890.1850
- Review Panel
- PM
- Submission Type